Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006

June 23, 2015 updated by: Affiris AG

A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Hall in Tirol, Austria, 6060
        • Landeskrankenhaus Hall Gedächtnisambulanz
      • Linz, Austria, 4020
        • LNK Wagner-Jauregg, Dept. of geriatrics
      • Salzburg, Austria, 5020
        • Christian Doppler Klinik, Univ. Klinik f. Neurologie
      • Vienna, Austria, 1090
        • MUW Klin. Pharmakologie und Klinik für Neurologie
      • Vienna, Austria, 1090
        • MUW, Klin.Abt.f. Biolog. Psychiatrie
      • Vienna, Austria, 1220
        • SMZ-Ost, Psychiatric Dep.
  • Croatia
      • Rijeka, Croatia, 51000
        • Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
      • Varaždin, Croatia, 42000
        • Opća bolnica Varaždin, Klinika za Neurologiju
      • Zagreb, Croatia, 10000
        • "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
      • Zagreb, Croatia, 10090
        • Psihijatrijska Bolnica Vrapče
  • Czech Republic
      • Praha, Czech Republic, 14950
        • University Thomayer Hospital
      • Praha, Czech Republic, 15006
        • University Hospital Motol, Clinic of Neurology
  • France
      • Bordeaux Cedex, France, 33076
        • CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
      • Bron, France, 69500
        • Hopital Neurologique Pierre Wertheimer
      • Dijon, France, 21033
        • Centre Hospitalier Universitaire (CHU) de Dijon
      • Montpellier Cedex, France, 34295
        • Centre Mémoire de Ressources et de Recherche, Service de Neurologie
      • Paris, France, 75651
        • Hôpital de la Pitié-Salpêtrière
      • Rennes Cedex, France, 35064
        • CHU de rennes Site Hôtel Dieu
      • Toulouse, France, 31059
        • Hôpital La Grave
  • Germany
      • Berlin, Germany, 14050
        • Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie
      • Hamburg, Germany, 20251
        • Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie
      • Leipzig, Germany, 04107
        • Arzneimittelforschung Leipzig GmbH, Studienzentrum
      • Mannheim, Germany, 68159
        • Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie
      • Munich, Germany, 81675
        • Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München
      • Nürnberg, Germany, 90402
        • Studienzentrum PD Dr. Steinwachs
      • Ulm/Donau, Germany, 89073
        • Neuropoint GmbH
  • Slovakia
      • Kosice, Slovakia, 04017
        • EPAMED, s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
  • Written informed consent
  • Availability of a partner/caregiver
  • Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
  • Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.

Exclusion Criteria:

  • Pregnant women.
  • Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
  • Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
  • History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
  • Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
  • Contraindication for MRI imaging
  • Presence and/or history of immunodeficiency (e.g., HIV infection).
  • Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.
  • Prior and/or current treatment with immunosuppressive drugs.
  • Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
  • Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1
AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations
Biological: AFFITOPE® AD02
Active Comparator: Group 2
AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations
Biological: Placebo
Biological: AFFITOPE® AD02

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite Measures of Primary Safety and Tolerability Endpoints
Time Frame: 19 months
  • Withdrawal criteria
  • Number of Adverse events (AEs)
  • Number of any serious adverse events (SAE)
  • Alzheimer's Disease Assessment Scale - Cognition (ADAScog)
  • Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)
19 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite Measures of Secondary Efficacy Endpoints
Time Frame: 19 months
  • Clinical Dementia Rating Sum of Boxes (CDR-sb)
  • Free and Cued Selective Reminding Test (FCSRT)
  • Standard neuropsychological test battery (CogState)
  • Mini-Mental State Examination (MMSE)
  • Investigator's global evaluation scale (IGE)
  • CDR [global aspects]
  • Neuropsychiatric Inventory (NPI) [behavior]
  • quality of life (QOL) -AD
19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiris AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruno Dubois, Prof., Centre des Maladies Cognitives et Comportementales, Federation des maladies du systeme nerveux, Hoptial de la Salpetriere, Pavillon Paul Castaignes (Sous-sol), 47-83 Bd de l'Hopital, 75651 Paris Cedex 13

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFF006A
  • 2012-005280-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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